- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07823738
Classic Versus Interfascial Axillary Block in Hand, Wrist, and Forearm Surgery
Comparison of Axillary Block and Interfascial Axillary Block in Terms of Block Success and Intraoperative Clinical Efficacy in Hand, Wrist, and Forearm Surgery: A Prospective Randomized Study
Hand, wrist, and forearm surgeries are commonly performed procedures with significant postoperative pain potential. Regional anesthesia of the brachial plexus via the axillary approach is one of the gold-standard techniques for distal upper-limb surgery. In the conventional (classic) axillary block, the median, ulnar, and radial nerves within the axillary sheath are individually targeted under ultrasound guidance; however, anatomical septations around the axillary artery may prevent homogeneous spread of local anesthetic, leading to a patchy block and reduced intraoperative success.
The interfascial axillary block is a modified approach in which local anesthetic is deposited into the fascial planes between the axillary muscles rather than directly into the nerve sheath, aiming for passive diffusion, homogeneous spread, and fewer needle manipulations. This prospective, randomized, single-center study compares the classic axillary block with the interfascial axillary block in patients undergoing hand, wrist, and forearm surgery, primarily in terms of surgical anesthesia adequacy (block success).
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
This is a prospective, randomized, single-center clinical trial conducted in a Department of Anesthesiology and Reanimation. Randomization is performed using the sealed-envelope method. A total of 110 patients (55 per group) aged 18-90 years, American society of anesthesiologists physical status I-III, scheduled for elective hand, wrist, or forearm surgery under ultrasound-guided regional anesthesia will be enrolled.
Group 1 (Classic Axillary Block) receives an ultrasound-guided block targeting the median, ulnar, and radial nerves perineurally/perivascularly within the axillary sheath. Group 2 (Interfascial Axillary Block) receives an ultrasound-guided injection of local anesthetic into the potential fascial planes between the axillary muscles, relying on passive diffusion.
The primary outcome is surgical anesthesia adequacy (block success). Secondary outcomes include block application time, sensory and motor block onset, rates of additional local infiltration and conversion to general anesthesia, intraoperative additional analgesic/sedation requirements, hemodynamic parameters, patient and surgeon satisfaction, and complications.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Korgün Ökmen, PhD.
- Numéro de téléphone: 05057081021
- E-mail: korgunokmen@gmail.com
Lieux d'étude
-
-
-
Bursa, Turquie (Türkiye), 16110
- Bursa Yuksek Ihtisas Training and Research Hospital
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- Aged 18-90 years
- American society of anesthesiologists physical status I-II-III
- Scheduled for elective hand, wrist, or forearm surgery
- Written informed consent obtained
Exclusion Criteria:
- History of local anesthetic allergy
- Coagulation disorder
- BMI > 40 kg/m²
- Infection at the block site
- Chronic pain syndrome
- Pregnancy
- Inability to communicate
- Need for emergency surgery
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Classic Axillary Block
Ultrasound-guided classic axillary brachial plexus block.
The median, ulnar, and radial nerves within the axillary sheath around the axillary artery are targeted individually by perineural/perivascular injection of local anesthetic.
|
Classic (perivascular/perineural) axillary brachial plexus block
|
|
Comparateur actif: Interfascial Axillary Block
Ultrasound-guided interfascial axillary block.
Local anesthetic is injected into the potential fascial planes between the axillary muscles rather than directly into the nerve sheath, allowing passive diffusion of the drug.
|
Interfascial (fascial-plane) axillary brachial plexus block.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Surgical anesthesia adequacy (block success)
Délai: 30 minutes after block
|
Complete sensory and motor blockade of the surgical field, allowing the operation to be completed without additional local infiltration or conversion to general anesthesia
|
30 minutes after block
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Block application time
Délai: intraoperative
|
time from needle insertion to withdrawal.
|
intraoperative
|
|
Sensory block onset time
Délai: 5., 10., 15., 30. minutes
|
Pin-Prick test in the median, ulnar, radial, and musculocutaneous dermatomes (0: normal, 1: blunt, 2: no sensation).
|
5., 10., 15., 30. minutes
|
|
Motor block onset time
Délai: 5., 10., 15., 30. minutes
|
5., 10., 15., 30. minutes
|
|
|
Intraoperative additional analgesic/sedation consumption
Délai: intraoperative
|
intraoperative
|
|
|
Patient and surgeon satisfaction
Délai: end of surgery
|
4-point Likert scale (1: very poor, 4: very good)
|
end of surgery
|
Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- BursaYIEAH-2026-1
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .